The Sex Hormones And Physical Exercise study
| ISRCTN | ISRCTN11633173 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11633173 |
| Protocol serial number | N/A |
| Sponsor | The National Cancer Fund (Koningin Wilhelmina Fonds [KWF]) (The Netherlands) |
| Funder | Dutch Cancer Society (Netherlands) |
- Submission date
- 26/09/2006
- Registration date
- 26/09/2006
- Last edited
- 25/08/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Evelyn Monninkhof
Scientific
Scientific
University Medical Center Utrecht (UMCU)
Julius Center for Health Sciences and Primary Care
Stratenum 6.131
P.O. Box 85500
Utrecht
3508 GA
Netherlands
| Phone | +31 (0)30 2509379 |
|---|---|
| e.monninkhof@umcutrecht.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | SHAPE: Sex Hormones and Physical Exercise |
| Study objectives | We hypothesise that exercise may reduce risk of breast cancer, either directly or indirectly through a reduction in abdominal fat mass, by favouring the sex hormone profile and decreased insulin. Because the association between breast cancer and endogenous estrogens is rather convincing, we designed the Sex Hormones and Physical Exercise (SHAPE) study on the effects of physical activity on these hormones. Furthermore, since androgens and insulin are suspicious risk factors for breast cancer, the effects of physical activity on these hormone levels are also investigated. Since the intervention programme is aimed at maximising fat loss, we can also investigate whether a potential relation between physical activity and endogenous hormones is mediated by the amount of total body fat or abdominal fat. If change in exercise level has a beneficial effect on the sex hormone and metabolic profile of postmenopausal women, increasing exercise is a possible breast cancer protective intervention. |
| Ethics approval(s) | Ethics approval received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | Reducing the risk of breast cancer |
| Intervention | 1. Intervention group: participants in this group will participate in an one year moderate intensity exercise programme 2. Control group: participants in this group will receive care as usual |
| Intervention type | Other |
| Primary outcome measure(s) |
Endogenous hormone levels (sex steroid hormones, insulin). |
| Key secondary outcome measure(s) |
1. Physical fitness, weight and the amount of total and intra-abdominal fat |
| Completion date | 01/09/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Female |
| Target sample size at registration | 189 |
| Key inclusion criteria | 1. Women aged 50 to 69 years 2. More than 12 months since last menses 3. Non-smokers (at least 12 months) 4. Sedentary: less than two hours per week of moderate sport activity (e.g. tennis, swimming, running, aerobics, fitness, volleyball) and not adherent to the international physical activity guideline. The international physical activity guideline states that every adult should accumulate 30 minutes or more of at least moderately intense physical activity for at least five days per week 4. Knowledge of the Dutch language 5. Agreement to be randomly assigned to either the exercise intervention or control group 6. Informed consent to participate in all screening and study activities |
| Key exclusion criteria | 1. Use of hormone replacement or oral contraceptives in past six months 2. Morbidly obese (Body Mass Index [BMI] more than 40) 3. BMI less than 22 4. Currently on or planning to go on a strict diet 5. Ever diagnosed with breast cancer 6. Diagnosis of other types of cancer in the past five years 7. Diabetes mellitus or other endocrine related diseases 8. Disorders or diseases (locomotor, optical, neurological, mental) that might impede the participation in the exercise programme 9. Alcohol or drug abuse 10. Maintenance use of corticosteroids 11. Use of beta blockers |
| Date of first enrolment | 01/01/2005 |
| Date of final enrolment | 01/09/2006 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
University Medical Center Utrecht (UMCU)
Utrecht
3508 GA
Netherlands
3508 GA
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 20/09/2009 | Yes | No | |
| Protocol article | protocol | 04/09/2007 | Yes | No |
